Clinical Trial: TEN1412

Lord Warner: My honourable friend the Minister of State, (Andrew Burnham) has made the following Written Ministerial Statement.
	On 19 April my predecessor the honourable member for Liverpool Wavertree (Jane Kennedy) informed the House of progress made by the Medicines and Healthcare products Regulatory Agency (MHRA) in investigating the incident that occurred with the phase 1 clinical trial for a drug in development known as TGN1412 (Official Report, House of Commons, col. 13–14WS). The MHRA is today publishing the final report of its investigations. A copy of the report has been placed in the Library and copies are available for honourable Members in the Vote Office.
	The report indicates that the adverse incidents did not involve errors in the manufacture of TGN1412 or in its formulation, dilution or administration to trial participants. The report does reference a number of procedural shortcomings that were brought to light by the MHRA's inspection. None of these was judged to have led to the adverse incidents suffered by the volunteers in this trial, but they are being followed up in the normal way through regulatory action with the company.
	The MHRA therefore confirms its conclusion set out in its interim report of 5 April that an unpredicted biological action of the drug in humans is the most likely cause of the adverse reactions in the trial participants. Monoclonal antibodies are a relatively new type of biological drug, although there are a number of them already licensed and in use. However, TGN1412 is a new class of monoclonal antibody which has a stimulatory mode of action affecting certain types of cell in the immune system. In this case, the resulting activity seen in humans was not predicted from apparently adequate preclinical testing. This is a complex scientific issue, which raises important scientific and medical questions about the potential risks associated with this type of drug and how to make the transition from preclinical testing to trials in humans.
	In the earlier Written Ministerial Statement it was also announced that my right honourable friend the Secretary of State had agreed to the establishment of an expert working group to consider what this incident reveals about the underlying science, and how clinical trials involving these types of products should be managed and authorised in the future. My right honourable friend has appointed Professor Gordon Duff to chair the expert group. Professor Duff has now identified, and appointed on behalf of the Secretary of State, the members of his group, who have today been announced.
	The terms of reference of the expert group are: to consider what may be necessary in the transition from preclinical to first-in-man phase 1 studies and in the design of these trials, with specific reference to biological molecules with novel mechanisms of action, new agents with a highly species-specific action and new drugs directed towards immune system targets; and to provide advice in the form of a report to the Secretary of State for Health for the future authorisation of such trials with an interim report to be provided within three months. We will provide a further report to the House when the expert group provides its interim report.
	The members of the group are as follows:
	Professor Gordon W Duff MA BM BCh PhD FRCP, FRCPE, FMedSci, Professor of Molecular Medicine & Director of Division of Genomic Medicine, Sheffield University: Chairman;
	Professor John I Bell MA DM FRCP FMedSci, Regius Professor of Medicine, Oxford University;
	Professor Dame Carol M Black CBE MD FRCP FMedSci, President of the Royal College of Physicians of London and Professor of Rheumatology, Royal Free Hospital, London;
	Professor Sir Leszek K Borysiewicz MB BCh FRCP F Med Sci, Deputy Rector, Imperial College London;
	Professor Janet H Darbyshire OBE MB ChB FMedSci FRCP FFPH, Director of the MRC Clinical Trials Unit, Co-Director of UK Clinical Research Network and Professor of Epidemiology, Royal Free and University College London Medical School;
	Professor Neva E Haites OBE MB ChB PhD MRCPath FRCPE, Professor of Clinical Genetics & Head of College and Vice-Principal, College of Life Sciences and Medicine, University of Aberdeen;
	Sir Bob Hepple QC FBA, Cambridge University and Chair of the Nuffield Council of Bioethics;
	Ms Amanda Hoey, Director, ConsumerHealth Consulting Ltd—Lay representative;
	Dr Stephen C Inglis BSc PhD, Director, National Institute for Biological Standards and Control (NIBSC);
	Professor Lars Klareskog, Professor of Rheumatology, Karolinsha University, Stockholm;
	Professor Robert Lechler MB, ChB, PhD, FRCP, FRCPath, FMedSci, Vice-Principal (Health), King College London;
	Professor Dr Johannes Löwer MSc, MD, President of the Paul Ehrlich Institute, Langen, Germany;
	Professor Andrew J McMichael MB BChir PhD CNAA FRCP FRS, Professor of Immunology, Oxford University;
	Professor Alexander F Markham BScPhD MB BS DSc FRCP FRCPath, Chief Executive Cancer Research UK and Professor of Medicine, St James University Hospital, Leeds;
	Professor B Kevin Park BSc PhD Hon MRCP FMedSci, Professor of Pharmacology & Head of Department of Pharmacology and Therapeutics, Liverpool University;
	Mrs Vivienne Parry, lay representative;
	Professor Munir Pirmohamed MC ChB PhD FRCP, Professor of Clinical Pharmacology, Liverpool University;
	Professor Mark J Walport MB BChir MA FRCP FRCPath F Med Sci, Director of the Wellcome Trust & Professor of Rheumatology/Immunology, Imperial School of Medicine, Hammersmith;
	Professor Herman Waldmann PhD, FRS FRCPath F Med Sci, Professor of Pathology, Sir William Dunn School of Pathology, Oxford.
	Observers:
	There will be a number of observers to the expert group from:
	The European Medicines Agency
	Department of Health
	Department of Trade and Industry— Biosciences Unit
	US Food and Drug Administration
	Pharmaceutical and Medical Devices Agency, Japan
	MHRA
	Agency of the German Government responsible for the regulation of biological medicinal products for humans and animals.

Lord Falconer of Thoroton: I have today laid before Parliament the City of London Corporation report on the City of London (Ward Elections) Act 2002, hereafter referred to as "the Act". The Act reformed and modernised the business element of the franchise for local elections in the City of London.
	The City of London Corporation submitted the report on the working of its new franchise arrangements to me pursuant to Section 7(1) of the Act.
	I am inclined to think that a further report will be required following the 2009 elections, however I will make a final decision on whether to ask the City to submit one, under Section 7(2) of the Act 2002, at the time.

Lord Sainsbury of Turville: I will be attending the Competitiveness Council in Brussels on 29–30 May 2006.
	Monday 29 May
	In the morning, there will be a policy debate on the EU Sustainable Development Strategy, centred around questions set by the presidency. There will be an update on the current work programme on better regulation, followed by an exchange of views. There will be a policy debate on the Commission's proposal for a directive on consumer credit, centred on questions set by the presidency. Over lunch and in the afternoon there will be discussion of the services directive, which the presidency has put on the agenda for political agreement.
	Tuesday 30 May
	There will be a discussion on the 7th Framework Programme for Research and Development, including the rules of participation, on which the presidency is seeking agreement on a general approach. There will also be a progress report by the Commission on the development of the European space policy and road map, followed by a report from the presidency of a recent conference on GMES (global monitoring for environment and security). In addition to the items listed above, there will be 11 items which will be taken under "any other business". There is not likely to be any debate on these items:
	Competitiveness clusters to promote industrial growth and to strengthen the regions in Europe (information from the Commission);
	Conference on REACH (Registration, Evaluation and Authorisation of Chemicals) (Vienna, 30–31 March 2006) (information from the presidency);
	Conferences related to consumer protection held during the Austrian presidency (information from the presidency);
	Proposal for a programme of community action in the field of health and consumer protection 2007 (progress report);
	Information on EU import duties on primary aluminium (information from the Polish delegation);
	Public procurement directives (information by German, French and Austrian delegations);
	Tourism policy (presentation by the Commission);
	Tourism Ministers conference (Vienna, 20–21 March 2006) (information from the presidency);
	Delivering on the modernisation agenda for universities: education, research and innovation. (information from the Commission);
	International Thermonuclear Experimental Reactor (ITER) (information from the Commission);
	Type approval of motor vehicles (information from the French delegation)

Lord Hunt of Kings Heath: My honourable friend the Parliamentary Under-Secretary of State for Work and Pensions (James Plaskitt) has made the following Written Ministerial Statement.
	The Employment, Social Policy, Health and Consumer Affairs Council will be held on 1 June in Luxembourg. My honourable friend, the Minister for Disabled People (Anne McGuire) will be representing the UK except for the item on the working time directive, for which the UK will be represented by my right honourable friend, the Secretary of State for Department for Trade and Industry (Alistair Darling) and my honourable friend, the Minister for Employment Relations and Minister for London (Jim Fitzpatrick). Health and consumer affairs issues are being taken on 2 June.
	The first item is a policy debate on the review of the EU sustainable development strategy. Member states were invited to submit a written response to three questions which have been tabled at all councils. Additional questions have been posed about social inclusion to Employment and Social Policy Ministers. The Minister will contribute to the debate by stating that the most relevant link between the work of this council and the EU sustainable development strategy is through its focus on generating economic prosperity, more and better jobs and increasing social inclusion.
	The second item is on social services of general interest. The Commission will give a presentation on its recent communication which addresses the area of the legal uncertainty arising from the situation whereby the European Court of Justice is developing the law on social services on a case-by-case basis. The Social Protection Committee has drafted an opinion on the communication and the revised draft services directive. It generally welcomes both documents.
	The council will reach partial general approach on both the proposal for a regulation of the European Parliament and of the Council implementing regulation (EC) No 883/04 on the co-ordination of social security schemes and the proposal for a regulation of the European Parliament and of the Council amending regulation (EC) No 883/2004 on the co-ordination of social security systems, and determining the content of annexe XI.
	Ministers will be expected to endorse political agreement on the amended proposal for a regulation of the European Parliament and of the Council establishing a European institute for gender equality. The proposal provides for the creation of a European gender institute to produce objective, reliable and comparative information on gender equality and data at national and European levels and to give visibility to gender equality. Its aim is to increase the opportunities for sharing knowledge, data and information on best practice, and facilitate networking.
	There will be council conclusions on the review of the implementation by the member states and the EU institutions of the Beijing platform for action. Following the United Nations Fourth World Conference on Women held in Beijing in 1995, the council asked member states to undertake an annual review of the implementation of the resulting platform for action. Each presidency concentrates on different areas. The Austrian presidency is looking at "women and health" and has produced a report and a set of indicators.
	There will be an endorsement of the joint contribution of the Employment Committee and the Social Protection Committee on flexicurity.
	There will be a progress report from the presidency on the proposal for a directive of the European Parliament and of the Council on improving the portability of supplementary pension rights. This is intended to make it easier for workers with occupational pensions to move around the EU.
	The council is being asked to reach political agreement on the amended proposal for a decision of the European Parliament and of the Council establishing a community programme for employment and social solidarity—PROGRESS. This is the EU-level spending programme for the period 2007–13, which will provide financial support for the implementation of the Community's objectives for employment and social affairs and the achievement of the Lisbon goals.
	The council is being asked to reach political agreement on the annual employment guidelines on the proposal for a council decision on guidelines for the employment policies of the member states. The guidelines set out the framework of common priorities for member states' employment policies. In 2005 the council agreed that the guidelines should run for three years under the refocused Lisbon strategy for jobs and growth. Member states will report on their employment policies in relation to the guidelines as part of the new national reform programmes, to be published in October.
	The council is also seeking political agreement on the amended proposal for a directive of the European Parliament and of the Council amending directive 2003/88/EC concerning certain aspects of the organisation of working time. The working time directive, adopted in 1993, regulates maximum working hours and entitlements to rest breaks for workers. It sets out a maximum average working week of 48 hours although the UK retains an individual opt out from this provision.
	Under "any other business" the presidency will give a report on proposals for a regulation of the European Parliament and of the Council establishing the European Globalisation Adjustment Fund. There are six written items on presidency conferences and information from the Portuguese delegation on the Council of Europe Ministers conference on family matters: "Changes in Parenting". The Commission is providing information on its recent communications on "Guidance on the posting of workers in the framework of the provision of services", "Implementing the partnership for growth and jobs: Making European a 'pole of excellence' on corporate social responsibility", and "Decent Work" and "European Year of Equal Opportunities for all 2007". I do not expect any debate on these items.

Baroness Scotland of Asthal: My right honourable friend the Secretary of State for the Home Department (John Reid) has made the following Written Ministerial Statement.
	I would like to correct an error contained in my Written Statement of 23 May (Official Report, House of Commons, col. 77WS) and to apologise for inadvertently misleading the House.
	In my Statement, I reported that four murderers and 23 other "most serious" offenders, including rapists and child sex offenders (who were among the 1,019 cases who were not considered for deportation before their release from prison) were detained in prison. I was subsequently informed that, of these, one murderer, one rapist and one child sex offender who had been detained have in fact since been released on bail by the asylum and immigration tribunal. In addition, I have been informed of eight other cases where the individual has been bailed, including four in the "more serious" category. I have been told that these bail applications were heard over the past two weeks and that more hearings are due to take place in the coming days.
	I have asked the department to re-check all the figures provided to the House in my Statement.